(132 days)
The DARCO® Headed Cannulated Screws are intended for use over a guide pin or wire for bone fracture fixation and bone fragment fixation. Wright Medical's washers may be used with the screws in cases where the patient has poor bone quality.
- Minimally invasive fracture / joint reconstructions .
- Multiple- fragment joint fractures ●
- Simple metaphyseal fractures .
- Simple epiphyseal fractures .
- Fractures of the head of the humerus o
- Fractures of the head of the tibia o
- Cooper fractures of the tibia O
- Fractures of the radius o
- Fractures of the wrist, ankle, elbow and shoulder .
- Scaphoid fractures and other fractures of the hand ●
- Metatarsal fractures and other fractures of the foot .
- Ligament fixation of the proximal humerus .
- Ligament avulsion injuries (Apohysis) ●
- Fractures of small joint bones ●
- Malleolar fractures o
- Navicular fractures o
- . Fractures of the calcaneus and talus
- Arthrodesis of the ankle joint .
- Avulsion fracture and metatarsal V .
- Fractures of the tarsal region .
The DARCO® Headed Cannulated Screws will be offered in various sizes, thread types, and lengths. The screws contain an optional washer will be made available with the system. The screws and washers are manufactured from titanium alloy.
The provided document is a 510(k) summary for a medical device called "DARCO® Headed Cannulated Screws". This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific acceptance criteria through a study with defined performance metrics in the way an AI/software device would.
Therefore, many of the requested categories (e.g., sample size, expert qualifications, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this particular document as it deals with a hardware medical device and a demonstration of substantial equivalence based on material and design characteristics, not an AI algorithm's performance.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material (Titanium alloy) | Identical to predicate device (aap Cannulated Screws) |
| Diameter | Similar to predicate device (aap Cannulated Screws) |
| Thread Types | Similar to predicate device (aap Cannulated Screws) |
| Lengths | Similar to predicate device (aap Cannulated Screws) |
| Indications for Use | Similar to predicate device (aap Cannulated Screws), with a limited scope chosen by the manufacturer |
| Performance (Mechanical) | Expected to perform "at least as well as the predicate screws" based on characterization of subject and predicate screws and available complaint data. |
| Safety and Effectiveness | Adequately supported by "substantial equivalence information, materials information, and comparison of design characteristics." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This submission is for a hardware medical device (bone screws), not a software/AI device. The "test set" in this context would refer to pre-clinical testing, such as material characterization and mechanical testing, comparing the subject device to the predicate device. The document states "full characterization of the subject and predicate screws" was performed, but does not provide specific sample sizes or details of the individual tests. No human data (clinical or retrospective/prospective) was used for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. As this is a hardware device submission, no expert-established ground truth for a test set (in the context of diagnosis or performance evaluation by experts) is described. The "ground truth" for demonstrating substantial equivalence lies in the physical and mechanical properties and design of the screws, evaluated against engineering standards and comparison to the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No adjudication method for a test set involving human interpretation is described, as this is not an AI/software device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is a hardware device, not an AI-assisted diagnostic tool. Therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This device is a physical medical implant (screws), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is based on the engineering specifications, material properties, design characteristics, and mechanical performance of the DARCO® Headed Cannulated Screws and their direct comparison to the predicate device (aap Cannulated Screws). Additionally, "available complaint data" for the predicate device was mentioned, implying real-world performance as part of the understanding of predicate safety and effectiveness.
8. The sample size for the training set
- Not Applicable. This device is a physical medical implant. There is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not Applicable. No training set exists for this device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.